Persistence of antibody responses against hepatitis B and whooping cough in healthy 4 to 5-year-old children who have previously been vaccinated with VAXELIS® or INFANRIX® hexa vaccines using two different vaccination schedules.
- Conditions
- Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).MedDRA version: 19.0Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 100000004865MedDRA version: 19.0Level: LLTClassification code 10069543Term: Hemophilus influenzae type b immunizationSystem Organ Class: 100000004865MedDRA version: 19.0Level: LLTClassification code 10069593Term: Pertussis immunizationSystem Organ Class: 100000004865MedDRA version: 19.0Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865MedDRA version: 19.0Level: LLTClassification code 10054180Term: Diphtheria immunizationSystem Organ Class: 100000004865MedDRA version: 19.0Level: LLTClassification code 10054183Term: Tetanus immunizationSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-000274-37-FI
- Lead Sponsor
- MCM Vaccine B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 760
An individual must fulfill all of the following criteria in order to be eligible for study enrolment:
1. Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS® or INFANRIX® hexa as part of the V419-007 or V419-008 study respectively;
2. Informed consent signed by the subject's parent(s) or legal representative.
Are the trial subjects under 18? yes
Number of subjects for this age range: 760
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting at least one of the following criteria will be ineligible for study enrolment:
1. Subject who has received any dose of HB containing vaccine at any time other than study vaccine in V419-007 or V419-008 study;
2. Subject with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study;
3. Subject who has received any dose of pertussis containing vaccine after completion of the V419-008 study;
4. Subject with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study;
5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*;
6. Subject who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*;
7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies;
8. Subject with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method